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Revance Therapeutics Inc (RVNC) Q4 2018 Earnings Conference Call Transcript

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Revance Therapeutics Inc  (NASDAQ: RVNC)
Q4 2018 Earnings Conference Call
Feb. 26, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to the Revance Fourth Quarter and Full Year 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. (Operator Instructions) As a reminder, this conference is being recorded today, February 26th, 2019.

I would now like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Please go ahead.

Jeanie Herbert -- Senior Director of Investor Relations and Corporate Communications

Thank you, Candice. Joining us on the call today from Revance's President and Chief Executive Officer, Dan Browne; Chief Financial Officer, Toby Schilke; Chief Operating Officer, Dr. Abhay Joshi; and Head of Commercial Aesthetics & Therapeutics, Dustin Sjuts.

Earlier today, Revance released financial results for the quarter and full year ended December 31st, 2018. If you've not received the news release or if you would like to be added to the company's distribution list, you can do so on the Investor Relations page of the company's website at www.revance.com.

During this conference call, Revance management will make forward-looking statements, including statements related to Revance's 2018 financial results and 2019 guidance; clinical development of our product candidates; business strategy and planned operations; anticipated precommercial and launch plans; and potential product candidates and technologies.

These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements, as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our quarterly report on Form 10-Q for the quarter ended September 30th, 2018, as filed with the SEC on November 2nd, 2018.

Revance cautions you not to place any undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations.

I will now turn the call over to Dan Browne. Dan?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Thank you, Jeanie. Good afternoon and thank you for joining our fourth quarter and year-end 2018 conference call. Our business model is to be fully integrated, premier neuromodulator provider, that can provide new solutions, the long standing unmet needs. We plan to address and expand the $4.5 billion global opportunity in both aesthetics and therapeutics.

Our DaxibotulinumtoxinA for Injection or DAXI will be the first and only next-generation premium product, which uses a proprietary peptide excipient technology to deliver unprecedented response rates and duration of effect. Revance's creating a whole new category of neuromodulator that has significant value across both aesthetic and therapeutic marketplaces. DAXI has not a need to short-acting neurotoxin.

The combination of high response rates and extended duration delivers a new user experience. In aesthetics, DAXI promises to provide safe, natural, enduring wrinkle reduction for consumers with just two treatments or less per year. In therapeutics, DAXI may improve the quality of life for patients, who suffer prolonged pain and debilitation from a variety of chronic therapeutic conditions, by providing a long-acting treatment option that results in better pharmacoeconomics.

To that end, Revance had a highly productive year in 2018. I'd like to express my gratitude that the Revance team, as we asked a lot and they worked tirelessly to deliver the SAKURA Phase 3 open-label safety study trial with exceptional results; initiate three important clinical programs to broaden our portfolio of therapeutic indications and signed two significant partnering agreements.

More specifically, in December, the SAKURA 3 results confirm the safety, efficacy and long-duration of effect for DAXI in treating glabellar lines. The SAKURA Phase 3 program represented the largest ever aesthetic neuromodulator clinical trial, which included up to three treatments and monthly follow-up conducted over a year and a half. DAXI was well tolerated and delivered unprecedented safety and efficacy across more than 3,800 treatments in total.

DAXI also recorded the highest 2-point composite efficacy response rates seen in Phase 3 glabellar trials at week-four, with high response rates carry through week-28 before patients returned to baseline. It is response rates over continuous key pre-specified time points that determines duration. That is where DAXI excelled. It's important to note DAXI demonstrated it's superiority using the most stringent FDA protocol standards. Time to loss of none or mild on the investigator scale remains the standard measure for duration, the goal post has not moved.

On the heels of our pre-BLA meeting completed in December, we believe our powerful Phase 3 clinical data along with well-established label precedence, will result in a strong and differentiated label, allowing for direct promotion of DAXI's extraordinary patient benefits in terms of safety, efficacy and duration.

In therapeutics, we initiated the ASPEN Phase 3 trial in cervical dystonia; a Phase 2 trial in planter fasciitis; and the JUNIPER Phase 2 trial in adult upper limb spasticity. All three trials are actively enrolling patients and we expect to have top line results in the second half of 2020.

We signed two significant strategic business development agreements, yielding $55 million in upfront cash payments. The first was with Mylan for potential biosimilar to the reference BOTOX. The second signed in December was within -- with Fosun Pharma, a leading biopharmaceutical company in Asia, to develop and commercialize DAXI in China in both aesthetic and therapeutic indications. The infusion of cash from these partnerships, as well as our recent stock offering, that put Revance in excellent position to execute our plans launched DAXI in aesthetics and advance our current therapeutic clinical trials.

Looking ahead, 2019 is shaping up as the year of rapid transition. We are laser focused on submitting our BLA package to FDA for DAXI, in the treatment of glabellar lines in the first half of this year, which puts us on track for a 2020 PDUFA date and launch. While other companies are trying to increase their doses of their current neuromodulators or tweak diluents to produce marginal improvements and performance. DAXI is delivering meaningfully longer duration and enhanced efficacy. And it is doing it with comparable amount of active curdorotoxin found in today's market leading short-acting products.

Our patented peptide technology stabilizes the neurotoxin molecule providing stability at room temperature for at least two years. And because DAXI is highly purified neurotoxin, it presented no immune responses in the SAKURA Phase 3 trials. Based on DAXI's highly differentiated product characteristics, our aesthetic launch will focus on four key areas; creating the long-acting neuromodulator category; redefining the value of long-lasting results; updating the treatment paradigm and resonating with today's consumer. We will continue to build our commercial team against these priorities.

Throughout 2019, Revance is planning significant podium publication and one-on-one presence in the physician community, highlighting DAXI'S unmatched efficacy and duration demonstrated in the SAKURA program. At the recent TOXIN 2019 meeting in Copenhagen, where we had two podium presentations and 11 posters. The main topic of discussion throughout the meeting hall was duration. It is the most desired attribute of a neuromodulator by physicians and patients alike.

As we look to commercial launch, we are expanding our robust clinical data package in the upper phase. Already initiating a study in forehead lines, soon to be followed by another study in crow's feet. In addition, we continue to advance our plans to fully monetize our manufacturing assets and analytic capabilities. Last week, we held the Biosimilar Initial Advisory Meeting with the FDA. At that meeting FDA provided guidance on their expectations for a development program to establish biosimilarity to BOTOX. Based on this feedback, we believe that at 351(k) pathway for the development of a biosimilar to onabotulinumtoxinA is viable. Successful completion of a biosimilar program could potentially result in approval for all 11 FDA approved BOTOX indications.

After review of the final advisory meeting, then it's expected in March, Mylan and Revance will plan to discuss the development path, timing in next steps. Revance is entering 2019 with tremendous momentum a broad neuromodulator pipeline and the capital to make it all happen, that covers the recent highlights.

Let me turn the call over to Toby to summarize our fourth quarter and year end results, then we'll have a few closing comments before the Q&A session. Toby?

Toby Schilke -- Chief Financial Officer

Thank you, Dan. The company met its 2018 financial guidance, with operating expenses of $146.4 million and a cash burn of $135.6 million. Revenue for the fourth quarter of 2018 consisted of a $0.5 million recognized from the upfront payment from Mylan under the biosimilar program. Please see the earnings release for the full year and year-end results.

We ended the year with $175.8 million in cash and short-term investments with no debt, when including the upfront payment from the Fosun pharma licensing agreement and the net proceeds from the recent public stock offering the same balance was $295.5 million as of January 31st, 2019. This provides the company a cash runway through 2020.

Today, we are issuing our 2019 guidance. We expect the 2019 GAAP operating expense to be in the range of $173 million to $185 million; and the non-GAAP operating expense, which excludes depreciation and stock-based compensation in the range of $148 million to $158 million, driven by increased research and development expenditure and launch preparation activities.

With the new aesthetics studies outlined in our earlier press release, three clinical programs on the therapeutic side and preparation to file the BLA under way Revance expects the 2019 non-GAAP research and development expense to be $93 million to $100 million. Revance's shares outstanding as of December 31st, 2018 were approximately 37 million, as of February 22nd, 2019 there were 44 million shares outstanding, with 48.4 million fully diluted shares.

And with that, I'll turn the call back to Dan.

Dan Browne -- Co-Founder, President and Chief Executive Officer

Thank you, Toby. Only Revance is providing true innovation, pioneering a new first-in-class long-acting neuromodulator with the proprietary peptide excipient technology that meets a clear unmet need. The neuromodulator market opportunity continues to grow double-digits in both aesthetics and therapeutics and we know DAXI can drive significant adoption, as it appeals not only to patients already in treatment, but will also attract new patients. DAXI addresses the lifestyles, the needs and convenience of today's consumer. We are validating DAXI in a range of doses, indications, anatomies and geographies to maximize the full potential of this next generation neuromodulator.

In the near term, we plan to enter the lucrative cash pay facial aesthetics arena, while expanding our R&D focus into a growing number of neuroscience indications. We have a clearly differentiated product set to drive value. Our success in aesthetics market will fuel our neuroscience pipeline and allow us to meet patient needs in the therapeutics market.

At the same time, success with a biosimilar allows us to participate in the short-acting neuromodulator category, including all the currently approved indications. The team and I look forward to updating you on our progress on future calls. In terms of travel schedule at the end of this week we'll in Washington, DC for the American Academy of Dermatology. In March, we'll be in Boston at the Cowen Conference followed by the Barclays Conference in Miami. In April, we will be at the Needham Conference in New York followed by non-deal road show on the East Coast. Let Jeanie know if you'd like to meet with us in your area.

With that, thank you all for joining us today. I will now open it up for questions. Operator?

Questions and Answers:

Operator

Thank you. (Operator Instructions) And our first question comes from Stacy Koo (ph) of Cowen and Company. Your line is now open.

Stacy Koo -- Cowen and Company -- Analyst

Hi, Dan and team. Thanks a lot for taking my questions. Congratulations on a great 2018. My first question, have you spoken to any clinicians about Evolus' Jeuveau? And if so what has been the feedback you're getting? If not, can you provide additional clarity on their commercialization efforts. Do you think that their competitive fears are warranted? How will the Jeuveau launch change the landscape and potentially impact DAXI when it's launched?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Stacey. Hi, this is Dan. Thank you for the question. We spend a lot of time with physicians, but quite frankly, they ask us predominantly about DAXI. This premium category is new, it's been long side, out side after for decades, we don't spend all our time talking about the Evolus product line that's something you need to talk to them about. I think for us it's about the differentiation with physicians. What makes DAXI unique? What makes it address their physician practices in a better way? And how do they get more patients into treatment? How do they get better outcomes? And we do that both in the aesthetics side, as well as the therapeutic side.

I think for us it's taking this really powerful SAKURA 3 data and making sure as much of that data makes it into the label, because we want the breadth this -- you have to realize this is the largest, longest followed aesthetic trial ever. We want to make sure that label is differentiated and we want to shift from the short-acting neuromodulators to the long-acting category, which we will be first and will be only for a period of time. So I think that's probably the best way to answer that question.

Stacy Koo -- Cowen and Company -- Analyst

Okay, thanks. And second question, can you provide some insight into your conversations with the FDA. What -- do you know exactly what they require for you and Mylan to prove biosimilarity?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Abhay, do you want to take that one?

Abhay Joshi -- Chief Operating Officer

Yeah, this is Abhay Joshi. So with regards to our biosimilar discussion with FDA, it is suffice to say this information that we provided to the FDA was in compliance with the draft guidance for industry, which is about how to have a formal meetings between FDA sponsors and applicants for the biosimilar users Fee Act. And with regards to that, we bought it -- we give an sufficient information dealing with the initial necessary data on -- and is the similarity, some functional characterization, clinical and non-clinical plans and that was the base of our discuss with FDA.

Stacy Koo -- Cowen and Company -- Analyst

Okay, that's great. Thank you.

Operator

Thank you. And our next question comes from David Amsellem of Piper Jaffray. Your line is now open.

David Amsellem -- Piper Jaffray -- Analyst

Thanks. So just a question on, how you're thinking about DAXI pricing given that the new entrant is coming into the market as a fairly deep discount or does that dynamic change your views regarding DAXI pricing. And then as a follow-up to that, can you just remind us, how you are thinking about not just pricing, but how you're going to make the margins for practices more attractive, if that is part of the strategy as well. Thanks.

Dan Browne -- Co-Founder, President and Chief Executive Officer

David, hi. We'll break this up into two parts, I'll take the first part, and Dustin will take the second part. I think for us is we really focus on the premium category and on the experience associated with that, I think when you look at the last 20 years, you had products that competed on price that market share has been fairly stable over a long period of time, and we've been in the 20% to 30% discount. And so I think for our perspective that's where the short-acting market is today, we really see the premium based on the data, the consumer experience, the convenience, the look and feel that comes with SAKURA that was reported in the Phase 3 program to support that premium price and we'll have more data next year on the therapeutic side as well. So I think for us is how do we sort of look at that technology and provide that practice, better economics and you want to sort of talk about the margin side of that, Dustin?

Dustin Sjuts -- Interim Head of Commercial, Aesthetics and Therapeutics

Yeah. I think we take a very thoughtful approach to this, right? If you look at why pricing is going up to the physician and down to the consumers, all products are offering zero innovation to what the consumer demands are or those unmet needs. With DAXI having the opportunity to meet the unmet need of the consumer, it gives us optionality to focus on what's the value of that treatment. What's the value of that convenience and what's the economics for the physician? So, it allows us an opportunity to look at both sides of it, we are not an opportunity, we're not in situation where we have to compete on price, we have an opportunity to address the unmet need with value, I think we'll be thoughtful over that, and we'll be bringing out more information on that as we get closer.

Dan Browne -- Co-Founder, President and Chief Executive Officer

David, I find it interesting, if you look at the TOXINS 2019 positions for at least we spoke to are not chasing price or chasing performance. And I think that's why you see everyone talking about duration, whether it's with the peptide of the Revance Technology or now trying to sort of resurrect sort of this concept around more units in different diluents, because they're all chasing duration. That is what people are chasing, not price. I think at the end of the day physicians know that they chase that price downward and that gets passed on to consumers. That's not attractive to their practices. So at the end of the day, this is all about innovation that grows markets, not price.

David Amsellem -- Piper Jaffray -- Analyst

That's helpful color. Thanks.

Operator

Thank you. And our next question comes from Annabel Samimy of Stifel. Your line is now open.

Nick Rubino -- Stifel -- Analyst

Good afternoon, everyone. This is Nick Rubino on for Annabel Samimy. Thanks for taking our questions. And so, first, congratulations on the exciting BIAM meeting, you guys had with Mylan. Is there any market or indication that's more readily accessible to you for the biosimilar or markets that you guys are excited to enter. And who kind of has more control over the direction of where you guys head with that?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Look, I think that the most attractive approach with the biosimilar, is it's all 11 indications from one development program, as opposed to doing an indication by indication, we're attracted to all. When you look at this neuromodulator, it split roughly 50/50 or 60/40 depending on how you look at it by geography. There is a role for this in both indications. In fact, is we're interested in both and we've made a tremendous investment in the capabilities here in the San Francisco based area, with on the manufacturing on the analytics side, we'll focus on where the market is going to long-acting addressing that need, but there will still be a short-acting market and with this enable us to monetize with the relationship with Mylan among a biosimilar that will have a role in both, so we don't favor one over the other. But I think when you look at the potential number of indications on the therapeutic side, it's a very attractive space for both companies, whether you're looking at long-acting DAXI or in the biosimilar.

Nick Rubino -- Stifel -- Analyst

Great, thanks. And actually, you just touched on, I guess, I'm going on the second question. But, so your internal production facility has been such a large factor, in terms of your partnership abilities and is going to be important for launch timing. Can you give us an update on the state of FDA inspections of your facilities, and then I guess just lastly, have you made any headway on a potential migraine study?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Abhay, do you want to take that one?

Abhay Joshi -- Chief Operating Officer

Yes, I'll take that one, so with regards to that FDA inspection as you guys all know, that once you file the BLA, we will receive a PI approved -- pre-approval inspection and that can have been any time within three to six months of our BLA filing, so we anxiously wait for that. We are fully prepared to accept Diego facility and when the time is right we will (inaudible) up that inspection. With regards to the migraine program, we are still evaluating the potential design of a chronic migraine study. We are also watching the migraine dynamics of the CGRPs and the new lines of treatment. As we mentioned you last time that our primary intent of migraine program is basically to evaluate how can we do better in the injection paradigm of currently 31 injections over reduced number of injections, and so we will provide you more update with expectation to maybe plan or trial and initiate that sometime in 2020 or late 2019.

Dan Browne -- Co-Founder, President and Chief Executive Officer

If I could come back to the facility, we think this is an asset that has tremendous shareholder value. There probably won't be another commercial scale, botulinum facility ever built in the United States again, it's the barriers to entry are just so high. We go through annual select agent approval and so that our base point is, we feel very confident in a pre-approval inspection, quality, analytics is really been at the forefront of our manufacturing operation. And I think, when you look at the Mylan partnership and the Fosun partnership. What really resonated with them, was the quality and our intense focus on drug substance and drug product at commercial scale. So we feel very confident with our capability, not only in those relationships, but as we build our own commercial business.

Nick Rubino -- Stifel -- Analyst

Alright. Great, thank you very much.

Operator

Thank you. And our next question comes from Tim Lugo of William Blair. Your line is now open.

Myles Minter -- William Blair -- Analyst

Hi guys, this is Myles on for Tim. Thanks for typing the questions and congrats on all the progress. Just a half on more about the migraine space, you mentioned that you're constantly evaluating how the space is evolving with BOTOX, but also the CGRP biologics. I'm really curious to hear your thoughts on where you think that injection number must come down to increase noncompliance for migraine patients. And even if we look further ahead with these oral CGRP antagonists, that are currently in clinical trials is a once-a-day pill for prevention. How a longer acting neurotoxin like RT002 would be positioned in that market, interested to hear thoughts on that?

Abhay Joshi -- Chief Operating Officer

Sure. Yes, so we're going -- as far as our thoughts on the injection paradigm. Obviously, the reason why we chose migraine is that, this is an opportunity with large segment, that established in growth market, there's a clear pathway and is a targeted specialty. So the only downside we see today is the number of injections that the patients have to go. And it's the only approved treatment for chronic migraine, until the CGRPs given to exist. And so we believe that it's very, very important for us, not to come in with the same number of injections, but very thoughtfully think about how we can reduce the number of injections. We are working right now with regards to what that number would be, if I know I would tell you, but we are working very closely with our KOLs to make sure that we achieve an optimal injection paradigm, and once we have that, we will definitely use that into a consideration to launch our clinical study sometime latter part of this year.

But they got the CGRP, I think the -- we are carefully tracking and monitoring what's happening out there to your point, yes, there are CGRPs, which have oral daily, there are no sub SubQ monthly, there are IV quarterly. And at end of the day, as we all believe that probably if the market that would coexist for both CGRPs and from migraine, there's is not a single winner here. There'll be a market for both, and that is why we're carefully monitoring the CGRP markets along with our chronic migraine indication of neurotoxin.

Dan Browne -- Co-Founder, President and Chief Executive Officer

Yes. And I'd say -- to add on to Abhay's points, there's also the opportunity to look at combination care, the CGRPs in the neuromodulators, as well as, where neuromodulators and the CGRPs have had patient failures. One of the things that was really resonated the TOXIN 2019 meeting in Copenhagen is, how many patients on either treatment still don't respond. So as we look at both the prophylactic treatment of chronic headache, as well as, other segments of this 40 million sufferers of chronic migraine headache, our view is neuromodulators aren't going away. And there are opportunities to create new treatment paradigms with DAXI.

Myles Minter -- William Blair -- Analyst

Beautiful. And I guess just as a follow-up to that, when you're thinking about designing one of these trials, you've made mentioned now that treatment failure patients. So would have potentially be as Phase 2 trial where we're enrolling, straight up standard prevention patients, but also a refractory population or maybe even like a cluster migraine population to try and tease pays out where RT002 might be a fit for these patients?

Dan Browne -- Co-Founder, President and Chief Executive Officer

I think this point we'll probably stay silent on the study design, I think what we typically do is once we dose the first patient we have a very comprehensive study design. I think we've still got some homework to do. I think that work is coming together quite nicely as we continue to learn more where the CGRP patients are playing out and how well the neuromodulators to continue to do. So, I think for us is we still want to do some homework and we'll get back to you later in the year, but hopefully some more information on that specific question.

Myles Minter -- William Blair -- Analyst

Okay, great. Appreciate the color and congrats again.

Operator

Thank you. And our next question comes from Seamus Fernandez of Guggenheim Securities. Your line is now open.

Etzer Darout -- Guggenheim Securities -- Analyst

Hi, this is Etzer filling in on for Seamus. Thanks for taking my question. Just one quick one for me. You commented earlier that you plan to meet with Mylan on next steps for biosimilar BOTOX. And I just wondered, following the conversations that you've had with the FDA, if you have a clearer sense of development timelines and when a biosimilar BOTOX could potentially enter the clinic? Thanks.

Dan Browne -- Co-Founder, President and Chief Executive Officer

We have no comment on the timeline, I think that we came out very encouraged with a very collaborative and productive meeting. I think the guidance that FDA provided on a 351 pathway was very helpful. And as we said in the press release, we believe it is possible to have a biosimilar for all 11 approved indications for BOTOX. We want to take time to digest the minutes, we'll look at our development plan, we have a framework right now, and we'll work carefully with Mylan and come back once we have better idea, when we would file an IND, and what that clinical development path would look like. But at this time, I think we feel very good coming out of this meeting that we know what needs to be done and the FDA has set the right level of expectations.

Etzer Darout -- Guggenheim Securities -- Analyst

Thank you.

Operator

Thank you. And our next question comes from Serge Belanger of Needham. Your line is now open.

Sean Hannan -- Needham & Co -- Analyst

Hey, this is Sean (ph) actually on for Serge. Thanks for the question. So I just have one, Allergan recently stated in their earnings call that the aesthetics users are trending younger due to this millennial movement, which they say has tripled in the last five years. So what kind of impact do you expect this type of trend will have, if any on DAXI or just the market in general?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Dustin, you want to take?

Dustin Sjuts -- Interim Head of Commercial, Aesthetics and Therapeutics

Yes, I think regardless of age, the unmet need around duration and convenience is met only by DAXI. There is no product in the space that addresses the need, whether the consumers are millennial or whether she is a consumer, that's been treated for a while. So we don't really see an impact overall in DAXI, we think how you market to consumers is definitely understood and we'll make sure that our plans are associated with what markets are growing or not, but the need for duration and convenience actually suits both, right, those that have been treated for a while and those that are on the sidelines for treatment. All products today tell the consumer the same story, only DAXI can talk to her in a different way regardless of how old she is.

Dan Browne -- Co-Founder, President and Chief Executive Officer

Yes, I would just add that we've said this repeatedly, we're still at a very high single-digit penetration with the number of consumers, who have the right age demographics, or right interest in aesthetic products, we are just focused on the nine out of 10, who are not in treatment and expanding this market in a material way, as we are in the existing market. We'll play a role in both, we're not afraid to compete on the -- in the existing space, because we have something fundamentally different as Dustin shared. It's differentiated, it's been sought after, but for us, it's really about expanding this pool, whereas when I think when you look over the last 20 years, there has been sort of a fixed share, because there's really you got some good companies and some good products that all work about the same. And so for us it's really go after what no one else has and get that on label in the most scientifically, clinically evidenced based way and then compete on differentiation.

Sean Hannan -- Needham & Co -- Analyst

Thanks.

Operator

Thank you. And our next question comes from Difei Yang of Mizuho. Your line is now open.

Difei Yang -- Mizuho -- Analyst

Hi, good afternoon and thanks for taking my questions. Just a couple quick ones. With regards to the BLA filing, could you update us if there are any gating items left or is it just a matter of putting together the package?

Abhay Joshi -- Chief Operating Officer

Yes, I can take that, Difei. This is Abhay Joshi, again. So, as you know for completing BLA, there are three or four major modules under Common Technical Document, CDD. And so we are busy right now trying to compile other documents. We just got our Phase 3 studies there in a month ago, we're trying to finishing, compiling -- clinical study reports, while that's basically its a procedural thing for us, and we hope that we can wrap that up in next few months.

Difei Yang -- Mizuho -- Analyst

Okay, thank you, Abhay. And then, I was wondering from the work that you have done, working with the physicians, interviewing them about patients preference. I was wondering, if there are common themes with regards to the ideal patient profiles on long-acting versus short-acting toxins?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Good question, Difei, it's nice to chat with you again. I think this was a question we tried to present objectively at JPMorgan Conference. Earlier this year, we had two physicians sort of speak to their current practices. Both are key opinion leaders, I think our objective physicians, who are highly respected. And I think that kind of worked through their practice on and where DAXI really resonates and as -- it was the earlier question about millennials, but I think you sort of look at those patients, who are either dropped out of treatment or don't want to jump into treatment, I think those are ideal candidates, those who are men. Men typically don't like to look at treatment, millennials probably don't need a lot of treatment. So this will be a premium-priced product. All those segments all play a role for a longer duration.

I think from our perspective, we still got additional work as we sort of think about this, but that convenience, that durability, that performance, that look really sort of dial-in all those segments. And so, I don't think there's one that jumps out at us at this point. And I think for us is how do you present this premium product in each of the segments, and then I think once you're in market, you'll be able to prioritize those.

Difei Yang -- Mizuho -- Analyst

Thank you, Dan for the additional color. Then my final question on pricing. I know we're still maybe 18 months -- 12 to 18 months away from launch. At a very high level, how do you think about pricing for the aesthetics market versus therapeutics market?

Dan Browne -- Co-Founder, President and Chief Executive Officer

Difei, I don't think we've been bashful about this. We see -- our pricing is a premium price over where the existing short-acting neuromodulators are, not just because it's convenient to price it higher, but there is actual specific clinical benefit, pharmacoeconomic benefit that we think warrants into a premium price. I think premium pricing will play a role into both. And I think for us, we've said that we have to make a fundamental decision to price our products based on maximizing share in aesthetics or to maximize value capture on the therapeutic side or we fit something in the middle. And that's the work that Dustin and his team are going through. They sort of understand where those lines break.

At the end of the day, I think we're less focused on maximizing our share at the expense of lowering our price. That's not the way that we're going to compete. We see a more apple-like model. We're going to provide a better experience and hopefully better performance and that will resonate with the patients and certainly physicians and patients alike so far had been very bullish on the premium product concept, but until we put it out there and they have to put their credit cards and cash down, you don't know for sure, but we're testing that pretty aggressively, but we're really pleased that -- look, this market is going to grow from innovation.

We're going to provide something that no one has done in 30 years, and I think we're confident based on the data we can get it on label. We think that's going to resonate in market and now it's just a matter of how we tell that story of how we set that price. And I think, we'll be very thoughtful and I think we'll come up with a right answer.

Difei Yang -- Mizuho -- Analyst

Thank you. Thanks for taking my question.

Operator

Thank you. And our next question comes from Sameer Kandola, Wells Fargo Securities. Your line is now open.

Sameer Kandola -- Wells Fargo Securities -- Analyst

Hi, thanks for taking my questions. So, I was just wondering what discount do you believe Evolus will launch as you rollout? And then, kind of, based on the commentary you already gave, do you believe RT002 will be a premium product to Jeuveau or to Allergan's BOTOX? Any commentary on that would be helpful. Thank you.

Dan Browne -- Co-Founder, President and Chief Executive Officer

You have to ask the Evolus folks on pricing of that product. It's not in our purview, and it's not up to us. Look, I think that we look at the goal standard of brand and we look at BOTOX, because we have great respect for that product for what that company, what that product has achieved. I think we understand when we went into this with our eyes wide open that we have to provide meaningful innovation to grow the market. And I think that though some would put the two companies against each other, I really don't think that either one of those companies is our direct competitor. We're trying to grow this space with a new technology that is then a base of evasive for many. And so wherever the others price their product, it's entirely up to them, but we understand that there is a great brand in market and we have to purviewing something out, if we're going to grow it and capture the share that we expect.

Sameer Kandola -- Wells Fargo Securities -- Analyst

Got it, and then maybe one quick follow-up on the biosimilar to BOTOX. How you're thinking about this product, potentially taking some market opportunity away from RT002. How do you think about that or how should we think about that?

Dan Browne -- Co-Founder, President and Chief Executive Officer

We don't see it taking away from RT002 is distinct. Its unique, it's fundamentally different. It's formulation is different, it's performance is different and I think that from our perspective, there will be a short-acting market, it's been there for a couple of decades. We get to have the good fortune of monetizing our investments in our manufacturing and analytics. But I think that the biosimilars have been discounted of biogenerics -- branded generics have been focused at about 30% discount. And for us, we want to sort of look at the premium side of this and we don't see it changing, because there isn't anything else like it.

Sameer Kandola -- Wells Fargo Securities -- Analyst

Got it. Thank you.

Operator

Thank you. And that concludes our question-and-answer session for today. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.

Duration: 41 minutes

Call participants:

Jeanie Herbert -- Senior Director of Investor Relations and Corporate Communications

Dan Browne -- Co-Founder, President and Chief Executive Officer

Toby Schilke -- Chief Financial Officer

Stacy Koo -- Cowen and Company -- Analyst

Abhay Joshi -- Chief Operating Officer

David Amsellem -- Piper Jaffray -- Analyst

Dustin Sjuts -- Interim Head of Commercial, Aesthetics and Therapeutics

Nick Rubino -- Stifel -- Analyst

Myles Minter -- William Blair -- Analyst

Etzer Darout -- Guggenheim Securities -- Analyst

Sean Hannan -- Needham & Co -- Analyst

Difei Yang -- Mizuho -- Analyst

Sameer Kandola -- Wells Fargo Securities -- Analyst

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